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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Breath Measurement
510(k) Number K963376
Device Name MICRO H2
Applicant
MICRO DIRECT, INC.
P.O. BOX 239
840 POWNAL ROAD
AUBURN,  ME  04210 -0239
Applicant Contact DAVID STASZAK
Correspondent
MICRO DIRECT, INC.
P.O. BOX 239
840 POWNAL ROAD
AUBURN,  ME  04210 -0239
Correspondent Contact DAVID STASZAK
Regulation Number862.1820
Classification Product Code
NRH  
Date Received08/27/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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